Minimally invasive rectal balloon apparatus

ABSTRACT

A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough, a balloon affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon, and a sleeve slidably affixed over the shaft. This sleeve is movable between a first position overlying the balloon and a second position away from the balloon. The sleeve has an aperture at an end thereof such that the balloon extends outwardly of this aperture.

CROSS-REFERENCE TO RELATED U.S. APPLICATIONS

Not applicable.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT

Not applicable.

REFERENCE TO AN APPENDIX SUBMITTED ON COMPACT DISC

Not applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus for facilitatingperformance of diagnostic and therapeutic treatment of disease.Particularly, the present invention relates to rectal balloons that areused for immobilizing the region surrounding the prostate duringpre-treatment simulation and target localization, as well as during thedelivery of radiation therapy to treat prostate cancer. Moreparticularly, the present invention relates to minimally invasive rectalprobes.

2. Description of Related Art Including Information Disclosed Under 37CFR 1.97 and 37 CFR 1.98.

Treatment of prostate cancer using radiation therapy is difficult due tothe prostate's position near radiation-sensitive tissues, and is furthercomplicated by prostate motion. Adenocarcinoma of the prostate commonlyoccurs in the posterior portion of the prostate gland which is in veryclose proximity to the rectal wall. To plan external beam radiationtreatment, urethrograms, CT scans and magnetic resonance imaging (MRI)have all been used to visually localize the prostate, as well as thenormal critical structures in the surrounding area.

U.S. Pat. No. 5,476,095 issued on Dec. 19, 1995, to Schnall et al.,describes an insertable pickup probe for use in providing diagnostic MRIimages. The pickup probe in its preferred embodiment is for use inimaging the male prostate and comprises an elongated shaft supporting aninflatable patient interface balloon at its distal end. The interfaceballoon comprises an inner balloon and an outer balloon, between which areceiving coil is positioned. A lumen for air supply is provided in theshaft for expanding the inner balloon against the outer balloon to placethe receiving coil in close proximity to the area of interest in orderto provide MRI images.

Typically, the planning of radiation therapy for the treatment ofprostate cancer involves the patient undergoing a CT-based simulationscan of the pelvis to determine the location of the prostate gland. Inthe simulation phase, the patient is placed on CT equipment that ispreferably similar to the radiation treatment equipment (except that itdoes not generate the high energy radiation beam). The simulationequipment is positioned to simulate the delivery of the sequence oftreatment beams prescribed by the treating oncologist. Normally, duringthe simulation procedure, CT images are acquired. These CT images allowthe oncologist to locate the position of the tumor and help tofacilitate the composition of a radiation treatment plan. This treatmentplan delineates the positions of the radiation equipment components fordelivery the treatment beams.

During the actual treatment phase, the patient is placed in the sameposition on the treatment equipment as in the simulation scans.Radiation-emitting devices are generally known and used for radiationtherapy in the treatment of patients. Typically, a radiation therapydevice includes a gantry, which can be swiveled around a horizontal axisof rotation in the course of a therapeutic treatment. A linearaccelerator is located in the gantry for generating a high-energyradiation beam for therapy. During treatment, the radiation beam isprovided by this equipment and is delivered to the patient at theprecise location as delineated by the physician during simulation. Afurther feature of radiation therapy involves portal images, which arecommonly used in radiation therapy to verify and record the patienttumor location. Portal images include manual (film) and electronicimages (EPI) taken before and/or after the treatment.

During external beam radiation therapy, radiation is directed to thetarget prostate which is near the rectal wall. A misdirected radiationbeam may perforate the rectal wall causing radiation proctitus (rectalbleeding). This toxicity is related to the total radiation doseprescribed and the volume of the anterior rectal wall receiving a highradiation dose. A major factor limiting radiation oncologists' attemptsto reduce the volume of the anterior rectal wall receiving a highradiation dose is the position of the prostate gland as well as theintrinsic motion up to 5 mm in the anterior to posterior directioncaused by rectal peristalsis. Accordingly, oncologists generally willadd a margin to the radiation field in order to ensure that the entireprostate gland receives the prescription dose. This margin is typicallyon the order of 5 to 15 mm. As a consequence, lower doses of radiationmay need to be used so as not to overexpose radiation sensitivestructures. However, this may lead to inadequate radiation treatment anda higher probability of local cancer recurrence.

U.S. patent Publication No. 2003/0028097, published on Feb. 6, 2003 toD'Amico et al., describes an immobilizer probe system and method. Thissystem has an insertable probe for immobilizing a region of interestduring staging and radiation therapy thereof. In particular, this deviceuses a balloon having a rectangular cross section connected to a shaft.The shaft extends to an end of the balloon so as to allow fluid flowthrough an interior of the shaft and into the balloon so as toselectively inflate the balloon once the balloon is installed into therectal cavity. The balloon, shaft and handle are bonded together so thatthey move radially as a single unit when torque is applied. A syringe isprovided which connects the shaft and serves as an air pump to deliver avolume-limited amount of air to the air lumen of the shaft to theballoon. A stop cock is provided to maintain the air within the balloon.

One of the problems with the subject of U.S. patent Publication No.2003/0028-97 is the discomfort associated installing the rectal balloonwithin the rectal cavity. In particular, a relatively sturdy and widediameter shaft is connected to a relatively large thick-walled balloon.Because the balloon is not supported by anything other than by theshaft, the balloon is formed of a relatively rugged and thick material.Because of the relatively large size of the shaft and the thick materialof the rectangular-cross section balloon, the installation of the rectalballoon creates a large amount of discomfort for a patient.Additionally, it is often difficult for the medical personnel to knowexactly how far within the rectum the balloon has been installed. It isdifficult to achieve a standardized and fixed position of the balloonduring each and every use. The medical personnel must generallyapproximate the desired position of the balloon within the rectalcavity. As such, a need has developed whereby the rectal balloon can beformed of a minimal diameter shaft and of a balloon of relatively thinmaterial.

It is a object of the present invention to provide a rectal balloonapparatus which is easy to use and easy to install.

It is another object of the present invention to provide a rectalballoon whereby the position of the balloon can be easily ascertained bymedical personnel.

It is a further object of the present invention to provide a rectalballoon apparatus which maximizes the comfort to the patient.

It is still a further object of the present invention to provide arectal balloon apparatus which is easy to manufacture and relativelyinexpensive.

These and other objects and advantages of the present invention willbecome apparent from a reading of the attached specification andappended claims.

BRIEF SUMMARY OF THE INVENTION

The present invention is a rectal balloon apparatus that comprises ashaft having a fluid passageway extending therethrough, a balloonaffixed over an end of the shaft such that the fluid passagewaycommunicates with an interior of the balloon, and a sleeve slidablyaffixed over the shaft. The sleeve is slidably movable between a firstposition overlying the balloon and a second position away from theballoon.

In the present invention, a handle is affixed to the shaft at an endopposite the balloon. The handle has a tube connecting thereto. Thistube communicates with the fluid passageway of the shaft. The tube has avalve connected thereto for selectively allowing a fluid to pass throughthe tube and the shaft so as to inflate the balloon.

The shaft extends through the balloon so as to have an end of the shaftcontacting an end of the balloon. This end of the shaft is curved. Theballoon is formed of a silicone material.

In the present invention, the sleeve has a first portion overlying theballoon when in the first position. The sleeve has a second portionoverlying the shaft when in this first position. A flange is formed atan end of the second portion opposite the first portion. The firstportion has a diameter that is greater than a diameter of the secondportion. The first portion resides in sliding contact with the shaft.The first portion has an aperture therein opposite the second portion.The balloon has an end extending outwardly of this aperture. The balloonis folded compactly over the shaft and interposed between an interior ofthe sleeve and the shaft.

The shaft has indicia formed on an exterior surface thereof relative toa position of the balloon. In particular, this indicia is indicative ofthe distance that the balloon is positioned within the rectum.

In an alternative form of the present invention, the sleeve hasperforations formed longitudinally therealong such that the sleeve canbe split apart when moved to the second position. As such, the sleevecan be detached from the shaft after the balloon has been installed intoits desired position.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a side elevational view, partially transparent, which showsthe rectal balloon apparatus with the sleeve in a first position.

FIG. 2 is a side elevational view of the rectal balloon apparatus of thepresent invention with the sleeve in a second position.

FIG. 3 is a illustration of the rectal balloon apparatus of the presentinvention with the sleeve removed from the shaft.

FIG. 4 is an isolated view showing the compact folding of the balloonover the end of the shaft.

FIG. 5 is an isolated view of the sleeve as used in the rectal balloonapparatus of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, there is shown the rectal balloon apparatus 10 inaccordance with the preferred embodiment of the present invention. Therectal balloon apparatus 10 includes a shaft 12 having a fluidpassageway extending therethrough. A balloon 14 is affixed over the end16 of the shaft 12. The fluid passageway of the shaft 12 can communicatewith the interior of the balloon 14 through holes 18 formed adjacent tothe end 16 of shaft 12. A sleeve 20 is slidably affixed over the shaft12. As illustrated in FIG. 1, the sleeve 20 is in a first position whichoverlies the balloon 14.

The shaft 12 is a generally longitudinal shaft which has the fluidpassageway extending through the center thereof. A handle 22 is affixedto the shaft 12 opposite the balloon 14. The handle 22 can have avariety of configurations. Ideally, FIG. 1 illustrates the handle 22 ashaving a rather square or octagonal configuration. However, variousshapes can be utilized within the concept of the present invention. Atube 24 is connected the handle 22 and extends so as to communicate withthe interior passageway of the shaft. Tube 24 is utilized so that air orsaline fluids can be delivered into the interior passageway of the shaft12 and, ultimately, into the interior of the balloon 14. A stop cock 26is connected to the tube 24 at an end thereof. A valve 28 facilitatesthe ability of the stop cock 26 to open and close so as to selectivelyallow the fluid to pass into the tube. A connector 30 allows the tube 24to be connected to a supply of the fluid. When the stop cock 26 isopened by the rotation of the valve 28, the fluid will flow through thetube 24, through the interior passageway of the shaft 12, and into theinterior of the balloon 14. The valve 28 can then be closed so as tomaintain the inflated configuration of the balloon 14. When theprocedure is finished, and the fluid needs to be removed from theballoon 14, the valve 28 of stop cock 26 can then be opened so as toallow for the release of fluid therethrough.

The opposite end 16 of the shaft 12 contacts the end 32 of the balloon14. The end 16 is suitably curved or dome-shaped so as to allow theshaft 12 to facilitate the introduction of the balloon 14 into therectal cavity. The shaft has markings 34 formed therealong. Markings 34are indicative of the distance that the balloon 14 has been insertedinto the rectal cavity. As such, the markings 34 provide a clearindication to the medical personnel of the desired location of therectal balloon 14.

The sleeve 20 is slidably affixed over the shaft 12 and is movablebetween the first position, as illustrated in FIG. 1, overlying theballoon 14 and a second portion away from the balloon 14 (as illustratedFIG. 2). The sleeve has a first portion 36 which overlies the balloonwhen the sleeve 20 is in the first position. The sleeve 20 also has asecond portion 38 which overlies the shaft 12 when the sleeve 20 is inthe first position. A flange 40 is formed at an end of the secondportion 38 opposite the first portion 36. Flange 40 facilitates theability to move the sleeve 20 between the first and second positions.The sleeve 20 also has an aperture 42 at an end opposite the flange 40.The end 32 of balloon 14 and the end 16 of shaft 12 extend outwardly ofthe aperture 42. The first portion 36 has a greater diameter than thatof the second portion 38. The second portion 38 is closely juxtaposedagainst the outer surface of the shaft 12. The balloon 14 is neatlyfolded compactly over the shaft 12 and between an interior of the secondportion 36 of sleeve 20 and the exterior of shaft 12.

In normal use, when it is desired to introduce the rectal balloonapparatus 10 of the present invention into the rectum of a patient, thesleeve 20 will be in the first position, as illustrated in FIG. 1. Theend 16 of the shaft 12, along with the end 32 of the balloon 14 and theaperture 42 of the sleeve 20, will allow the rectal balloon apparatus 10to be easily inserted into the rectum of the patient. Because of thestructure of the sleeve 20, the shaft 12 can be of a minimal diameter,because the structural strength of the shaft 12 does not have to be verygreat. The shaft 12 can be flexible and of very small diameter. Thestructural integrity for insertion is facilitated by the rigid structureof the sleeve 20. Similarly, the balloon 14 can be made of a relativelythin-walled material, such as silicone. Since the balloon 14 is neatlydisposed within the interior of the sleeve 20, it does not have to havethe thick walls of the prior art in order to withstand the forcesimparted during the insertion of the apparatus 10 within the rectum. Theproper positioning is caused by the sliding of the sleeve 20 through therectum. The desired location of the balloon 14 is established by notingthe positioning through the use of the indicia 34.

FIG. 2 illustrates the apparatus 10 after the apparatus has beeninstalled within the rectum. Once the apparatus 10 has been installed,the sleeve 20 is pulled to its second position along the shaft 12 byimparting a force onto the flange 40 in the direction toward the handle22. As such, the aperture 42 at the end of the sleeve 20 will pass overthe exterior surface of the balloon 14. The fluid can be introducedthrough the tube 24 and through the interior passageway of the shaft 12so as to inflate the balloon 14. The balloon 14 can be designed so as tohave a seating area so that the prostate can be properly positionedthereon. After the procedure has been completed, the balloon 14 can bedeflated and easily pulled outwardly of the rectum in its deflatedcondition.

FIG. 3 shows an isolated view of the apparatus 10 of the presentinvention with the sleeve 20 removed. Under normal use, and as will bedescribed hereinafter, the sleeve 20 can be suitably perforated so thatit can be split apart and removed from the shaft 12. In FIG. 3, it canbe seen that the indicia 34 has numerical reference associatedtherewith. These numerical references are indicative of the distancethat the balloon 14 has been inserted into the rectum.

FIG. 4 shows that the balloon 14 is neatly folded and compressed overthe outer diameter of the shaft 12. The shaft 12 will have a rounded end16 abutting the end 32 of the balloon 14. As such, a comfortable roundedprofile is provided at this end 32. The balloon 14 has an end 50 whichis sealed over the outer diameter of the shaft 12.

FIG. 5 is an isolated view of the shaft 20. Importantly, in FIG. 5, itcan be seen that the sleeve 20 has perforations 60 extendinglongitudinally therealong. These perforations are arranged such thatwhen the sleeve 20 is pulled toward the handle 22, proper pulling forcescan cause the sleeve 20 to split longitudinally therealong so that thesleeve 20 can be permanently removed from the shaft 12. The sleeve 20also has an aperture 42 formed at an end opposite to the flange 40. Theaperture 42 allows the end 32 of the balloon 14 to extend slightlyoutwardly therefrom. As such, the end 42 will create a smooth contour,in combination with the end 32, so as to facilitate the ease ofinsertion of the apparatus 10.

The foregoing disclosure and description of the invention isillustrative and explanatory thereof. Various changes in the details ofthe illustrated construction can be made within the scope of the presentclaims without departing from the true spirit of the invention. Thepresent invention should only be limited by the following claims andtheir legal equivalents.

1. A rectal balloon apparatus comprising: a shaft having a fluidpassageway extending therethrough; a balloon affixed over an end of saidshaft such that said fluid passageway communicates with an interior ofsaid balloon; and a sleeve slidably affixed over said shaft and movablebetween a first position overlying said balloon and a second positionaway from said balloon.
 2. The apparatus of claim 1, further comprising:a handle affixed to said shaft at an end opposite said balloon.
 3. Theapparatus of claim 2, said handle having a tube connecting thereto, saidtube communicating with said fluid passageway of said shaft.
 4. Theapparatus of claim 3, said tube having a valve means connected thereto,said valve means for selectively allowing a fluid to pass through saidtube and said shaft to said balloon.
 5. The apparatus of claim 1, saidshaft extending through said balloon so as to have an end of said shaftcontacting an end of said balloon.
 6. The apparatus of claim 5, said endof said shaft being rounded.
 7. The apparatus of claim 1, said balloonbeing formed of a silicone material.
 8. The apparatus of claim 1, saidsleeve having a first portion overlying said balloon in said firstposition, said sleeve having a second portion overlying said shaft insaid first position.
 9. The apparatus of claim 8, said sleeve having aflange at an end of said second portion opposite said first portion. 10.The apparatus of claim 8, said first portion having a diameter that isgreater than a diameter of said second portion, said second portionresiding in sliding contact with said shaft.
 11. The apparatus of claim8, said first portion having an aperture at an end opposite said secondportion, said balloon having an end extending outwardly of saidaperture.
 12. The apparatus of claim 1, said balloon being foldedcompactly over said shaft and interposed between an interior of saidsleeve and said shaft.
 13. The apparatus of claim 1, said shaft havingindicia formed on an exterior surface thereof relative to a position ofsaid balloon.
 14. The apparatus of claim 1, said sleeve having aperforation formed longitudinally therealong such that said sleeve canbe split apart when moved to said second position.
 15. A rectal balloonapparatus comprising: a shaft having a fluid passageway extendingtherethrough; a balloon affixed over an end of said shaft such that saidfluid passageway communicates with an interior of said balloon; and asleeve positioned over said balloon, said sleeve having an aperture atan end thereof, said balloon having an end extending outwardly throughsaid aperture, said balloon being interposed between said shaft and aninner surface of said sleeve.
 16. The apparatus of claim 15, said sleeveslidably affixed over said shaft and movable between a first positionoverlying said balloon and a second position away from said balloon. 17.The apparatus of claim 15, said sleeve having a first portion overlyingsaid balloon and a second portion overlying said shaft.
 18. Theapparatus of claim 17, said sleeve having a flange at an end of saidsecond portion opposite said first portion.
 19. The apparatus of claim15, said shaft having indicia formed on an exterior surface thereofrelative to a position of said balloon.
 20. The apparatus of claim 15,said sleeve having a perforation formed longitudinally therealong suchthat said sleeve can be split apart.